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BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery

NCT ID: NCT01225822

Last Updated: 2014-05-19

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1973 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Brief Summary

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The primary objective of this study is to establish the dose-response relationship with regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg b.i.d. and 300 mg quaque die(q.d) ) in preventing venous thromboembolism(VTE) in patients undergoing primary elective total hip and knee replacement.

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Dose-confirmatory Bridging Study in Total Hip Replacement

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Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Study Groups

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BIBR 1048 50 mg bis in die(b.i.d)

BIBR 1048 50 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus one placebo matching enoxaparin 0 mg once a day for the treatment period

Group Type EXPERIMENTAL

BIBR 1048

Intervention Type DRUG

50 mg b.i.d BIBR 1048 capsule twice a day for 5-10 days of treatment period

BIBR 1048 150 mg b.i.d

BIBR 1048 150 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period

Group Type EXPERIMENTAL

BIBR 1048

Intervention Type DRUG

150 mg b.i.d BIBR 1048 capsule twice a day for 5-10 treatment period

BIBR 1048 225 mg b.i.d

BIBR 1048 225 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period

Group Type EXPERIMENTAL

BIBR 1048

Intervention Type DRUG

225 mg b.i.d BIBR 1048 capsule twice a day for 5-10 treatment period

BIBR 1048 300 mg quaque die(q.d)

BIBR 1048 150 mg q.d once a day plus placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period

Group Type EXPERIMENTAL

BIBR 1048

Intervention Type DRUG

300 mg q.d BIBR 1048 capsule for 5-10 treatment period

Enoxaparin 40 mg subcutaneous(s.c)

placebo matching BIBR 1048 0 mg twice a day plus enoxaparin 40 mg s.c once a day for the treatment period

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

Enoxaparin 40 mg s.c once a day for 5-10 days of treatment period

Interventions

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Enoxaparin

Enoxaparin 40 mg s.c once a day for 5-10 days of treatment period

Intervention Type DRUG

BIBR 1048

50 mg b.i.d BIBR 1048 capsule twice a day for 5-10 days of treatment period

Intervention Type DRUG

BIBR 1048

150 mg b.i.d BIBR 1048 capsule twice a day for 5-10 treatment period

Intervention Type DRUG

BIBR 1048

225 mg b.i.d BIBR 1048 capsule twice a day for 5-10 treatment period

Intervention Type DRUG

BIBR 1048

300 mg q.d BIBR 1048 capsule for 5-10 treatment period

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients scheduled to undergo a primary elective total hip or knee replacement.
2. Male of female being 18 years or older.
3. Patients weighing at least 40 kg.
4. Written informed consent for study participation.

Exclusion Criteria

1. Bleeding diathesis, constitutional or acquired coagulation disorders.
2. Major surgery or trauma(e.g., hip fracture) within the last 3 months.
3. Cardiovascular disease
4. Any history of haemorrhagic stroke, intracranial or intraocular bleeding or cerebral ischaemic attacks lasting more than 24 hours and / or with cardiovascular pathological findings.
5. Deep vein thrombosis(DVT), gastrointestinal or pulmonary bleeding, gastric or duodenal ulcer within the last year.
6. History of or acute intracranial disease
7. Liver disease
8. Renal disease
9. Use of long-term anticoagulants or antiplatelet drugs within 7 days prior to hip/knee replacement operation.
10. Pre-menopausal women who are not surgically steriles, are nursing and are of child-bearing potential and are not practising acceptable methods of birth control
11. Known allergy to contrast media
12. Thrombocytopenia
13. Allergy against heparin.
14. Active malignant disease or current cytostatic treatment.
15. Treatment with an investigational drug in the past month.
16. Leg amputee
17. Known alcohol or drug abuse
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1160.19.43004 Krankenhaus der Barmherzigen Schwestern Linz

Linz, , Austria

Site Status

1160.19.43002 Orthopädisches Spital Speising

Vienna, , Austria

Site Status

1160.19.43001 A.ö. Krankenhaus d. Statutarstadt Wiener Neustadt

Wiener Neustadt, , Austria

Site Status

1160.19.32002 V.U.B. Jette

Brussels, , Belgium

Site Status

1160.19.32004 UZ Gent

Ghent, , Belgium

Site Status

1160.19.32005 Virga Jesseziekenhuis

Ghent, , Belgium

Site Status

1160.19.32006 Boehringer Ingelheim Investigational Site

Huy, , Belgium

Site Status

1160.19.32007 C.H.U. de Tivoli

La Louvière, , Belgium

Site Status

1160.19.42004 University Hospital Brno

Brno-Bohunice, , Czechia

Site Status

1160.19.42001 Hospital Kladno

Kladno, , Czechia

Site Status

1160.19.42006 Hospital Mlada Boleslav

Mladá Boleslav, , Czechia

Site Status

1160.19.42003 University Hospital Ostrava

Ostrava, , Czechia

Site Status

1160.19.42005 University Hospital Plzen

Pilsen, , Czechia

Site Status

1160.19.42009 University Hospital Na Bulovce

Prague, , Czechia

Site Status

1160.19.45042 Orthopedic Surgical Clinic

Frederiksberg, , Denmark

Site Status

1160.19.45045 Gentofte Hospital

Hellerup, , Denmark

Site Status

1160.19.45043 Herlev Hospital

Herlev, , Denmark

Site Status

1160.19.45041 Hørsholm Sygehus

Hørsholm, , Denmark

Site Status

1160.19.45044 Orthopedic Surgical Dept.

Silkeborg, , Denmark

Site Status

1160.19.35802 Keski-Suomen keskussairaala

Jyväskylä, , Finland

Site Status

1160.19.35801 Oulun yliopistollinen sairaala, Leikkaus- ja tehohoidon yks.

Oulu, , Finland

Site Status

1160.19.33004 Div

Illkirch-Graffenstaden, , France

Site Status

1160.19.33007 Clinique du Mail

La Rochelle, , France

Site Status

1160.19.33009 Hôpital Edouard Herriot

Lyon, , France

Site Status

1160.19.33006 Clinique Mutualiste

Saint-Etienne, , France

Site Status

1160.19.33008 Clinique de l'Atlantique

Saint-Herblain, , France

Site Status

1160.19.36003 Sándor Péterfy Hospital

Budapest, , Hungary

Site Status

1160.19.36001 Kálmán Pándy County Hospital

Gyula, , Hungary

Site Status

1160.19.36004 Bács-Kiskun County Hospital

Kecskemét, , Hungary

Site Status

1160.19.36002 Albert Szent-Györgyi Medical and Pharmacological Center

Szeged, , Hungary

Site Status

1160.19.36005 Szent György Hospital

Székesfehérvár, , Hungary

Site Status

1160.19.39003 U. O. Ortopedia e Traumatologia

Bergamo, , Italy

Site Status

1160.19.39005 Modulo Coordinazione Dipartimentale di Ricerca e Anestesia

Bologna, , Italy

Site Status

1160.19.39002 Fondazione Centro S. Raffaele

Milan, , Italy

Site Status

1160.19.39001 IRCCS Policlinico San Matteo

Pavia, , Italy

Site Status

1160.19.39004 Ospedale di Circolo di Varese

Varese, , Italy

Site Status

1160.19.31001 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

Site Status

1160.19.31003 Boehringer Ingelheim Investigational Site

Hilversum, , Netherlands

Site Status

1160.19.31005 Hengstdal 3

Nijmegen, , Netherlands

Site Status

1160.19.31006 Boehringer Ingelheim Investigational Site

Sittard, , Netherlands

Site Status

1160.19.31004 Boehringer Ingelheim Investigational Site

Zwolle, , Netherlands

Site Status

1160.19.47003 Helse Sunnmøre HF, Ålesund sykehus

Ålesund, , Norway

Site Status

1160.19.47001 Nordlandssykehuset HF, Bodø

Bodø, , Norway

Site Status

1160.19.47004 Martina Hansens Hospital

Bærum Postterminal, , Norway

Site Status

1160.19.47008 Martina Hansens Hospital

Bærum Postterminal, , Norway

Site Status

1160.19.47007 Sykehuset Innlandet HF, Avd. Elverum

Elverum, , Norway

Site Status

1160.19.47005 Haugesund sjukehus HF

Haugesund, , Norway

Site Status

1160.19.47002 Sykehuset Telemark HF, Avd. Skien

Skien, , Norway

Site Status

1160.19.27001 Dept. of Haematology

Johannesburg, , South Africa

Site Status

1160.19.27002 Suite 203

Johannesburg, , South Africa

Site Status

1160.19.46002 Kirurgavdelningen

Falköping, , Sweden

Site Status

1160.19.46001

Gothenburg, , Sweden

Site Status

1160.19.46004 Ortopediska kliniken, Länssjukhuset, Halmstad

Halmstad, , Sweden

Site Status

1160.19.46003 Ortopediska kliniken, Länssjukhuset i Kalmar

Kalmar, , Sweden

Site Status

1160.19.46007 Kungälvs sjukhus

Kungälvs, , Sweden

Site Status

1160.19.46005 Kirurg Ortopediska kliniken, Sjukhuset i Lidköping

Lidköping, , Sweden

Site Status

1160.19.46008 Ortopediska Institutionen

Linköping, , Sweden

Site Status

1160.19.46009 Sahlgrenska Universitetssjukhuset, Mölndal

Mölndal, , Sweden

Site Status

1160.19.46006 Boehringer Ingelheim Investigational Site

Varberg, , Sweden

Site Status

Countries

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Austria Belgium Czechia Denmark Finland France Hungary Italy Netherlands Norway South Africa Sweden

Other Identifiers

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1160.19

Identifier Type: -

Identifier Source: org_study_id

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